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Completed

NCT Number: NCT02526407

The Impact of Creative Interventions on Symptoms of Postnatal Depression

Post-natal depression (PND) is anticipated to affect 12.9% of new mothers with at least 75,000 cases per year in the UK alone. However, despite this, there is currently a worrying lack of support for new mothers, with data suggesting that 64% of healthcare trusts in the UK do not have a strategy for treating postnatal depression, and flaws in the current pharmacological and psychological treatment models. Consequently, research into promising psychosocial interventions such as music is critical to developing new paradigms for treating postnatal depression.

This project is an ambitious programme of research that investigates the effects of music on postnatal depression through two phases: a questionnaire study and an intervention study. This record is for the intervention study. The questionnaire study has a separate record. We are accepting host hospital sites for both.

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Key information

Conditions

Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Performance Science, Royal College of Music, London, United Kingdom

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About this study

The study tests the effectiveness of singing interventions led by the Royal College of Music at Chelsea and Westminster Hospital as a psychosocial tool to reduce the occurrence and effects of postnatal depression. It triangulates psychological, physiological, and biological data in a randomised control design to provide a comprehensive insight into the intervention's effects in comparison to a more common psychosocial intervention for new mothers (play groups) and a control group of no psychosocial interventions. The study aims to recruit 50-80 women into each of the three interventions (150-240 total).

The study will used a mixed-method methodology comprising validated psychological scales, in-depth qualitative interviews and observations and biomarker analysis. If results are promising, there are plans in place to scale the singing intervention to more hospitals and community settings.

Phase B will be open to NHS sites within the region of Chelsea and Westminster Hospital London from which women could travel to the sessions to take part.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women who have a child up to 9 months old
  • Symptoms suggestive of PND at a minimum score of 10 on the EPDS

Exclusion criteria

  • Outside the limits of the number of weeks pregnant/post birth
  • Living outside England
  • Refusal to participants

Treatment and study plan

Singing

Behavioral

Sessions will be led by a professional practitioner assisted by students from the Royal College of Music. Participants will learn songs with their babies and help to create new musical material together.

Group play

Behavioral

Sessions will be led by a professional practitioner assisted by students from the Royal College of Music. Participants will take part in group play activities.

Primary outcomes

  1. Postnatal depression

    Time frame: Change from baseline at 6 weeks and 10 weeks

    Measured with the Edinburgh Postnatal Depression Scale

Secondary outcomes

  1. Mental wellbeing

    Time frame: Change from baseline at 6 weeks and 10 weeks

    Measured with the short Warwick-Edinburgh Mental Wellbeing Scale

  2. Self-esteem

    Time frame: Change from baseline at 6 weeks and 10 weeks

    Measured with the Rosenberg Self-esteem scale

  3. Social functioning

    Time frame: Change from baseline at 6 weeks and 10 weeks

    Measured with the Social Provisions Scale

  4. Inflammatory immune response

    Time frame: Change from baseline at 6 weeks and 10 weeks

    Measured with saliva samples to test for cortisol and cytokine activity

Sponsors and collaborators

Lead sponsor

Royal College of Music

Other

Collaborators

  • Chelsea and Westminster NHS Foundation Trust
  • Imperial College London

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 18, 2015
Registry last updated
Apr 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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